In lieu of an abstract, here is a brief excerpt of the content:Socrates' Trial and Conviction of the Jurors in Plato's ApologyDougal BlythI am going to argue in this paper that, in the three speeches constituting his Apology of Socrates, Plato presents the judicial proceedings that led to Socrates' execution as having precisely the opposite significance to their superficial legal meaning. This re-evaluation will lead to some reflections on the politics of Socrates' defence, and, similarly, on Plato's own aims in (...) writing the Apology. I want to show not only that the trial as portrayed demonstrates an inevitable dereliction of duty by the democratic jury, but also, more interestingly, that throughout the proceedings Socrates understands the meaning of the trial precisely in terms of his anticipation of the jurors' judicial incapacity.In the prooimion to his defence speech, Socrates requests that the jurors ignore his manner of speaking and concentrate on whether his case is just, "since this is a judge's virtue (), while that of a rhêtôr is to speak the truth" (18a5-6, cf. 35c2-5). We can gloss the expression "a judge's aretê" in this context as his function, or responsibility.1 Socrates claims that he, himself, fulfills his own responsibility as a defendant to tell the truth (17b4-c4, 33c1-2, cf. 34b5, 35b9-c2) in a speech that asserts his exemplary piety in Apollo's service and his beneficial influence on the Athenian youth. But if, in claiming that he is innocent of the charge, Socrates does tell the truth, then those jurors who thereupon convict him of impiety and corruption, and subsequently sentence him to death, have failed in their duty to judge rightly.My claim is that Socrates sees the trial as a test of the jurors' abilities. It is characteristic of Socrates to test people regarding their concern for virtue and justice, a habit to which he devotes extended discussion during his defence, even dramatising it provocatively in a central passage (29d7-e5) that I aim shortly to analyse in detail. Moreover, Socrates specifically withholds from the jury the title of dikastai or judges; he does finally award the title in his address following the sentence, but only to those who have voted [End Page 1] to acquit him (40a2-3).2 The possibility thus emerges that Socrates has treated the legal proceedings all along as a moral (and intellectual) test, or trial, of the empanelled jurors themselves, to see whether they are capable of the legal function to which they have been allotted. In that case, Socrates is putting on trial, not just those individual citizens, but the very legal system of democratic Athens.Socratic irony and truthfulnessBefore considering Socrates' own explicit judgement during those final remarks on the jurors' moral offence and punishment, I should first address briefly the issue of Socrates' irony. In the past, some writers have asserted that this irony involves him in not telling the truth about himself during his defence, in which case the jury might well have been justified in convicting him. Actually, there does seem to be a consensus among the more extended treatments of the Apology that have emerged during the last decade, at least on the point that Plato presents Socrates as committed to making as sincere an attempt at a defence of his case as is consistent with his philosophical commitment to virtue, and so to telling the truth.3I shall not re-argue this point in detail, but shall take it to be secured by two basic considerations: consistency with the Crito would require Socrates to recognise a legal obligation to make a sincere attempt at defence while his obligation to Apollo to continue his mission in Athens if possible would motivate that attempt with the goal of acquittal.4 Instead, I want to show what role irony does have in Socrates' defence, given that his principled law-abidingness requires him to attempt to persuade the jury, in accordance with truth and justice, that he is innocent (cf. 19a6-7, 18a7-b1, 18e5).Where Socrates acknowledges the obligation to defend himself, he remarks on the difficulty he faces, a difficulty that has resulted from the slander to which he has long... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Socrates' Trial and Conviction of the Jurors in Plato's ApologyDougal BlythI am going to argue in this paper that, in the three speeches constituting his Apology of Socrates, Plato presents the judicial proceedings that led to Socrates' execution as having precisely the opposite significance to their superficial legal meaning. This re-evaluation will lead to some reflections on the politics of Socrates' defence, and, similarly, on Plato's own aims in (...) writing the Apology. I want to show not only that the trial as portrayed demonstrates an inevitable dereliction of duty by the democratic jury, but also, more interestingly, that throughout the proceedings Socrates understands the meaning of the trial precisely in terms of his anticipation of the jurors' judicial incapacity.In the prooimion to his defence speech, Socrates requests that the jurors ignore his manner of speaking and concentrate on whether his case is just, "since this is a judge's virtue (), while that of a rhêtôr is to speak the truth" (18a5-6, cf. 35c2-5). We can gloss the expression "a judge's aretê" in this context as his function, or responsibility.1 Socrates claims that he, himself, fulfills his own responsibility as a defendant to tell the truth (17b4-c4, 33c1-2, cf. 34b5, 35b9-c2) in a speech that asserts his exemplary piety in Apollo's service and his beneficial influence on the Athenian youth. But if, in claiming that he is innocent of the charge, Socrates does tell the truth, then those jurors who thereupon convict him of impiety and corruption, and subsequently sentence him to death, have failed in their duty to judge rightly.My claim is that Socrates sees the trial as a test of the jurors' abilities. It is characteristic of Socrates to test people regarding their concern for virtue and justice, a habit to which he devotes extended discussion during his defence, even dramatising it provocatively in a central passage (29d7-e5) that I aim shortly to analyse in detail. Moreover, Socrates specifically withholds from the jury the title of dikastai or judges; he does finally award the title in his address following the sentence, but only to those who have voted [End Page 1] to acquit him (40a2-3).2 The possibility thus emerges that Socrates has treated the legal proceedings all along as a moral (and intellectual) test, or trial, of the empanelled jurors themselves, to see whether they are capable of the legal function to which they have been allotted. In that case, Socrates is putting on trial, not just those individual citizens, but the very legal system of democratic Athens.Socratic irony and truthfulnessBefore considering Socrates' own explicit judgement during those final remarks on the jurors' moral offence and punishment, I should first address briefly the issue of Socrates' irony. In the past, some writers have asserted that this irony involves him in not telling the truth about himself during his defence, in which case the jury might well have been justified in convicting him. Actually, there does seem to be a consensus among the more extended treatments of the Apology that have emerged during the last decade, at least on the point that Plato presents Socrates as committed to making as sincere an attempt at a defence of his case as is consistent with his philosophical commitment to virtue, and so to telling the truth.3I shall not re-argue this point in detail, but shall take it to be secured by two basic considerations: consistency with the Crito would require Socrates to recognise a legal obligation to make a sincere attempt at defence while his obligation to Apollo to continue his mission in Athens if possible would motivate that attempt with the goal of acquittal.4 Instead, I want to show what role irony does have in Socrates' defence, given that his principled law-abidingness requires him to attempt to persuade the jury, in accordance with truth and justice, that he is innocent (cf. 19a6-7, 18a7-b1, 18e5).Where Socrates acknowledges the obligation to defend himself, he remarks on the difficulty he faces, a difficulty that has resulted from the slander to which he has long... (shrink)

Across America, especially in the aftermath of 9/11, parents rely on K12 schooling to prepare their children for the shocks, the perils, and especially the bright possibilities that are part of our warp-speed future. A new generation of school staffers is forging a fresh learning partnership with youngsters for whom creative computer-based schooling is as natural as breathing.

In this commentary on the previous paper it is explained that screen-detected Duct Carcinoma In Situ is effectively a new disease of unknown natural history. It is therefore impossible that 'the doctor knows best' and it is therefore both in the patient and the public's best interests that such cases are submitted to the rigours of the randomised controlled trial. Inevitably this brings the ethical dilemma of how to explain to patients the uncertainty and how to involve them in a (...) rational decision to take part in the randomised controlled trial. It is argued that as well as there being a collective benefit for future generations of women, that we should resolve this problem now, the individual woman is likely to benefit from being treated according to a strict protocol. Nevertheless the time of diagnosis is paradoxically not the best time for a patient to become aware of these matters and it is about time that the lay public and the opinion formers recognized their responsibility to become acquainted with the benefits and the needs of the randomised controlled trial in anticipation of the day when they themselves will be patients. (shrink)

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in (...) a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (shrink)

Ongoing and anticipated COVID-19 human challenge studies in the UK may advance our understanding of COVID-19 and facilitate the licensure of safe, effective, and easily deployable next-generation COVID-19 vaccines and boosters. We argue that international volunteer recruitment for COVID-19 human challenge trials can help promote diversity in these trials and ensure a sufficient number of eligible volunteers, both of which will increase the benefits of challenge research. We explore the ethical ramifications of dealing with unfair background conditions of (...) global vaccine injustice to expand medical research, and conclude that international recruitment for COVID-19 human challenge trials can be conducted ethically provided that several robust protections are in place for volunteers. (shrink)

I anticipate someone who dismisses Sophocles as mere literary craftsperson of high skill, arguing that such craftspeople turn up generationally and that the credit should go to the mythmakers.

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative (...) entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

In order to systematically evaluate perceptual anticipation between experts and non-experts for different kinds of combat sports, we needed to perform a comprehensive assessment. In this systematic review and meta-analysis, we searched four English-language and three Chinese-language databases that used expert/non-expert research paradigms, to explore perceptual anticipation in combat sports. We employed a random effects model for pooled analyses using the inverse variance method. We included 27 eligible studies involving 233 datasets in this meta-analysis. We observed large effect (...) sizes for the differences between experts and non-experts in both response accuracy and reaction time. We also observed substantial differences between experts and non-experts in the mean duration of visual fixations per trial, but not in the visual fixation duration. Taken together, high-level combat athletes have more advantages in perceptual anticipation than lower-level athletes, showing faster and more accurate responses when facing the opponent's attacks, as well as focusing on fewer points of visual fixations than novice athletes. Different types of combat sports and stimulus presentations affect perceptual anticipation abilities to varying extents in relation to outcome measures, with more pronounced expertise in a stimulus that is closer to real-world situations.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021226343, PROSPERO CRD42021226343. (shrink)

This article contributes to Science and Technology Studies on vulnerability by putting cyborgs at center stage. What vulnerabilities emerge when technologies move under the skin? I argue that cyborgs face new forms of vulnerability because they have to live with a continuous, inextricable intertwinement of technologies and their bodies. Inspired by recent feminist studies on the lived intimate relationships between bodies and technologies, I suggest that sensory experiences, material practices, and cartographies of power are important heuristic tools to understand the (...) vulnerabilities of hybrid bodies. Based on an analysis of how patients in the Netherlands and the United States cope with appropriate and inappropriate implantable cardioverter defibrillator shocks, I describe how defibrillators introduce two new kinds of vulnerabilities: vulnerability as an internal rather than an external threat, and as harm you may try to anticipate but can never escape. Despite these vulnerabilities, some heart patients don’t position themselves as passive victims of faulty machines. They actively engage in material practices of resilience by using magnets to stop inappropriate shocks. I conclude that anticipating and taming the improper working of technologies inside bodies constitutes a new form of invisible labor that is crucial to diminishing the existential uncertainties of cyborgs. (shrink)

Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges associated with (...) the launch of clinical trials to evaluate already approved drugs. In our discussion, we follow the ethics framework for prioritization of COVID-19 clinical trials proposed by Michelle N Meyer and colleagues (2021). We focus on four criteria: social value, scientific validity, feasibility, and consolidation/collaboration. We claim that launching amantadine trials was ethically justified. Although the scientific value was anticipated to be low, unusually, the social value was expected to be high. This was because of significant social interest in the drug. In our view, this strongly supports the need for evidence to justify why the drug should not be prescribed or privately accessed by interested parties. Otherwise, a lack of evidence-based argument could enhance its uncontrolled use. With this paper, we join the discussion on the lessons learned from the pandemic. Our findings will help to improve future efforts to decide on the launch of clinical trials on approved drugs when dealing with the widespread off-label use of the drug. (shrink)

The article discusses the criteria for authentic humanity within the moral paradigm of Russian philosophy. In Russian philosophy, the disciplines of ethics and anthropology are intertwined, as the question of human nature is primarily addressed from a moral perspective. The article primarily focuses on the interplay between faith and conscience, a topic that is approached and resolved differently within the context of Russian philosophy compared to Western European philosophy. For instance, the concept of “elimination of the ethical,” a fundamental aspect (...) of S. Kierkegaard’s existential philosophy, is discussed. The transcendence of ethical rationalism through a leap of faith, exemplified by Abraham’s act, forms the essence of authentic Christian ethics. It explores how faith is challenged by ethics, which requires not blind faith, but rational behavior in accordance with the widely accepted norms of social morality. The article highlights the conflict between existential faith and social ethics as the primary contradiction identified by S. Kierkegaard. The author revisits the ideas of F.M. Dostoevsky, N.A. Berdyaev, and others to illustrate that within the context of Russian philosophy, the critical situation is less about the anticipation of death and more about the moral anguish of conscience arising from the evil and falsehood prevalent in the world, a sentiment shared by diverse individuals like V.S. Solovyov and V.M. Shukshin. This perspective significantly redefines the concept of the existential in Russian philosophy, equating it with profound moral reflection. In discussing philosophical and anthropological issues under the “post-human threat,” the author introduces the concept of “conscientious faith.” This concept, serving as a fundamental anthropological unit, posits that it is the conscience, with its appeal to personal moral responsibility, that reveals the moral essence of an individual, thereby establishing human uniqueness. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Grand Theory on Trial:Kafka, Derrida, and the Will to PowerNina Pelikan StrausIn summa: so that man may respect himself he must be capable of doing evil.(Nietzsche, The Will to Power)1IThe following pages offer evidence that in The Trial Kafka invents characters who deploy a Nietzschean-sourced language of deconstruction related to what we now call theory; that in "Before the Law" Kafka's priest deconstructs The Law to which K. is (...) subjected, and that Kafka exposes the discursive devices by which laws can be deconstructed. Kafka's text then opens the way to another kind of deconstruction of that-which-is-already-deconstructed as performed by Jacques Derrida in his 1987 essay, "Before the Law."2 Although this claim may seem self-evident or rhetorically circular to some readers of Kafka and his commentators, it is the result of years of puzzlement concerning the impact of Grand Theory in American criticism.This puzzlement, often accompanied by antagonism, is shared by critics whose essays comprise Patia's and Corral's Theory's Empire: An Anthology of Dissent. The 2005 volume includes major reassessments of poststructuralist theory, notably Derrida's, by Tzetan Todorov, Thomas Nagel, M. H. Abrams, Kwame Anthony Appiah, Frederick Crews, René Welleck, David Bromwich, and others. While the deconstructionist idea of the arbitrariness of the signifier appears to be a central target of these critics' analysis, it is precisely the arbitrariness of the signifier called the Law that Kafka explores in The Trial.Kafka's intended relation to what he exposes has been much debated. [End Page 378] Stanley Corngold refers to the "undecidability" of Kafka's work and its "narrative mood of neutrality."3 The emphasis on "undecidability" in Kafka can be viewed as symptomatic of the influence of French Theory embraced by the American literary academy in the 1970s and 1980s. This latter view of Kafka's writing contrasts sharply with an earlier view, such as Hannah Arendt's, that The Trial, for all its ambiguity and multivalence, carries precise political meanings and warnings that Kafka fully intended. The deconstructionist moment did not bury convictions such as Adorno's or Canetti's that "from the beginning, Kafka sided with the humiliated,"4 or that for "a generation of early readers Joseph K.'s arrest was... a prophetic anticipation of the fate awaiting Hitler's victims."5 But deconstruction's skeptical effect undermined the certitude that Kafka was a politically important novelist. For its detractors, the deconstructionist view that there is "nothing outside of the text" ignores that texts like Kafka's have shaped human lives and human history. Wellek, who helped to introduce French theory to American literature departments, now asserts that theory has destroyed literary studies, while Frederick Crews argues that "Derrida's judgment that 'there is nothing outside the text' automatically precludes recourse to evidence." In Crews's view, "both Derrida and his myriad followers think nothing of appropriating and denaturing propositions from systems of thought whose premises they have already rejected." Thomas Nagel goes further in condemning "post-modern relativism" as a "quick fix" which puts reason to sleep. In Theory's Empire, Derrida's language is described as a "maze," a "prison house of language," a "limbo of combined attention and nonassertion."6The arguments against deconstruction theory can scarcely be summarized here, but a sampling of the commentaries in Theory's Empire on Derrida can lead us through and eventually back to what is or isn't at political stake in reading The Trial. Two questions are of concern: How much of Kafka's political acumen does Derrida ignore or misread in his commentary on "Before the Law"? And: to what degree do Derrida's rhetorical devices and ingenious language games resemble the language of the Courtiers who torture Joseph K.? What might such an analogy imply? Other questions follow, such as David Bromwich's very important ones. "About the status of Derrida's procedures there was always a puzzle," he writes. "Was deconstruction a technique proper to the commentator, and necessary as a tactic against the naïve constructionism of the author? Or was it something the author's writing practiced for itself, in... (shrink)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the (...) waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood - the standard treatment for hemorrhagic shock - is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)

There is little published literature on the ethical concerns of stakeholders in HIV vaccine trials. This study explored the ethical challenges identified by various stakeholders, through an open-ended, in-depth approach. While the few previous studies have been largely quantitative, respondents in this study had the opportunity to spontaneously identify the issues that they perceived to be of priority concern in the South African context. Stakeholders spontaneously identified the following as ethical priorities: informed consent, social harms, collaborative relationships between research (...) stakeholders, the participation of children and adolescents, access to treatment for participants who become infected with HIV, physical harms, fair participant and community selection, confidentiality, benefits, and payment. While there is some speculation that research in developing countries poses special ethical challenges, overall no issues were identified that have not been anticipated in international guidance, literature and popular frameworks. However, the South African context affords a distinctive gloss to these expected issues; for example, respondents were concerned that the predominant selection of black participants may perpetuate racist practices of apartheid. Stakeholders should be aware of contextual factors impacting on the implementation of ethical principles. We make a series of recommendations for South African trials, including amendments to the ethical-legal framework and research policies, and, for further research. (shrink)

Sometimes doing what’s right depends on anticipating how people will react when you do the right thing. Consider two aspects of challenge trial payments discussed by Lynch and colleagues. Th...

Adolescence has been linked to an enhanced tolerance of uncertainty and risky behavior and is possibly connected to an increased response toward rewards. However, previous research has produced inconsistent findings. To investigate whether these findings are due to different reward probabilities used in the experimental design, we extended a monetary incentive delay task by including three different reward probabilities. Using functional magnetic resonance imaging, 25 healthy adolescents and 22 adults were studied during anticipation of rewards in the VS. Differently (...) colored cue stimuli indicated either a monetary or verbal trial and symbolized different reward probabilities, to which the participants were blinded. Results demonstrated faster reaction times for lower reward probabilities in both age groups. Adolescents were slower through all conditions and had less activation on a neural level. Imaging results showed a three-way interaction between age group x condition x reward probability with differences in percent signal change between adolescents and adults for the high reward probabilities while adolescents demonstrated differences for the lowest. Therefore, previous inconsistent findings could be due to different reward probabilities, which makes examining these crucial for a better understanding of adolescent and adult behavior. (shrink)

Ethically permissible clinical trials must not expose subjects to risks that are unreasonable in relation to anticipated benefits. In the research ethics literature, this moral requirement is typically understood in one of two different ways: as requiring the existence of a state of clinical equipoise, meaning a state of honest, professional disagreement among the community of experts about the preferred treatment; or as requiring an equilibrium between individual and collective ethics. It has been maintained that this second interpretation makes (...) it mandatory to minimize the number of patients receiving the treatment that will eventually be shown to be inferior by the trial. This requirement has led to the development of adaptive trials, i.e., trials in which treatment allocation is determined by data accumulated during interim analysis. Many statisticians argue that in some circumstances—typically with potentially high benefits, as in the much discussed ECMO trial—adaptive design is the only ethically permissible experimental design. Nevertheless, some proponents of clinical equipoise argue that adaptive trials are neither ethically required nor permissible. More specifically, they argue that clinical trials using adaptive designs fail to meet the moral requirement of clinical equipoise, since these trials presuppose an epistemic state that is incompatible with a physician’s duty of care to her subjects. This paper emphasizes that the debate is to a large extent resting on an epistemological confusion. Specifically, I argue that this response conflates two different conceptions of statistical evidence, and that recognizing this distinction elucidates an epistemological framework in which adaptive trials are both consistent with and recommended by the moral requirement of clinical equipoise. (shrink)

Objectives: There are indications that institutional review board members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio of a specific phase II breast cancer clinical trial.Participants and methods: The trial was evaluated by means of a questionnaire administered to 43 members of IRBs at six academic hospitals and specialised cancer centres in the Netherlands. The questionnaire addressed: identification and (...) estimation of inconvenience, toxicity, psychosocial distress, and benefits of trial participation to patients; identification and estimation of benefits to future patients and medical science; assessment of the trial’s RBR; and assessment of its ethical acceptability.Results: Most IRB members expected trial participation to involve fairly or very serious inconvenience, fairly severe to sometimes life-threatening toxicity, and serious psychological and social consequences. Conversely, the perceived likelihood of benefits to patients was modest. Most regarded the study as important, and the balance between risks and benefits to be favourable, and believed that the protocol should be approved. The IRB members’ final judgement on the trial’s ethical acceptability was significantly correlated with their RBR assessment of the protocol.Conclusions: Because most patients who participate in clinical trials hope this will prolong their lives, it is suggested that patient information should better describe the anticipated benefits—for example, the likelihood of prolonging life. This would allow patients to make decisions regarding participation based on realistic expectations. (shrink)

Background This pilot study evaluated the speaking book ‘What it means to be part of a clinical trial’. The book aims at empowering populations with information on their rights and responsibilities when enrolled in clinical research. Wide publication of the book—at significant cost—is anticipated. It is important that the book is evaluated within the communities for whom it is intended, and the necessary changes (if any) are made, before translation and large-scale publication takes place. Objective The objective of the study (...) was to measure the efficacy and ease of use of the book. Methods Participants were recruited from a catering company. Participants were questioned on their knowledge of clinical trials and were then given the book. Instructions for use of the book were given to one group (‘experimental’ group). The other group (‘control’ group) was not given any instructions. A week later, the investigators returned, repeated the knowledge questions and asked ‘ease of use’ questions. Results A two-way repeated measure of covariants showed a statistically significant positive increase in knowledge of clinical trials among the intervention group (p=0.02). Results for the control group displayed trends that were not statistically significant. Percentage analysis of ‘ease of use’ questions proved that the book is easy to use, although some changes would be beneficial. Conclusion This study revealed that the speaking book is easy to use. It significantly increased knowledge of clinical trials among the study sample if instructions on use of the book were provided. (shrink)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the (...) waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood—the standard treatment for hemorrhagic shock—is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)

Although the study of the affective components involved in predicting physical activity is spreading faster and faster, there is a lack of studies testing their role when promoting physical activity through message interventions. In the present study, we considered these components by focusing on how anticipated affective reactions and emotional processing of the messages influence receivers’ affective attitude toward physical activity, concurrent behavior, and future intention. A sample of 250 participants was involved in an intervention relying on prefactual messages promoting (...) physical activity. All messages were sent through a research app and were focused on the expected consequences of exercising. Four experimental conditions involving messages differing as to their outcome sensitivity framing were compared to a control condition. Results showed that reading gain and non-gain messages enhanced the positive affective attitude toward physical activity, compared to control. Enhanced affective attitude after the intervention increased, in turn, self-reported physical activity and future intention. Interestingly, gain messages were even more persuasive for people with a low level of positive anticipated affective reactions. Furthermore, their effectiveness was especially attributable to the elicitation of hope in receivers. Discussion focuses on the advantages of considering affective components and their implications when promoting physical activity. (shrink)

I taught for 8 years at a moderate evangelical liberal arts college. At one faculty meeting the topic turned to the challenge of dealing with controversial topics in the classroom, a pressing question given that many of our students came from extremely conservative backgrounds. One faculty member commented that he and his colleagues in the sciences avoided problems by never using the word “evolution” in the classroom. A number of us from the humanities immediately expressed shock and dismay. In (...) response, our colleague reassured us that science faculty were indeed teaching evolution, but they had learned they could be spared student resistance and parental phone calls by replacing the word “evolution” with “development.”I was reminded of this while reading Adam Shapiro’s fine book, Trying Biology: The Scopes Trial, Textbooks, and the Antievolution Movement in American Schools. Central to Trying Biology is the argument that the Scopes Trial was not the inevitable result of an eternal con .. (shrink)

Two experiments were run to demonstrate the presence of a partial reinforcement extinction effect (PREE) and a partial punishment effect (PPE) 4 weeks after training in a 1-trial/day procedure. In the PREE paradigm, two groups of animals were trained to run a straight alley for food reward; one group was rewarded on every trial (CRF), whereas the other was rewarded on only 50% of the trials (PRF). In the test phase, extinction, no reward was present on any trial. Four (...) weeks after the end of acquisition, and subsequent to 7 days of CRF retraining, PRF animals showed greater resistance to extinction than did their CRF controls. The PPE paradigm resembled the PREE paradigm in all aspects, except that mild electric foot shock, together with the food reward, was used instead of nonreward on 50% of the acquisition trials. In the test phase, all animals were shocked and given a food reward on every trial. Four weeks after the end of acquisition and retraining, the animals with previous experience of shock in acquisition showed greater resistance to punishment than did their controls. (shrink)

The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because these findings may be beneficial (...) to patients and their families. Communicating individual BRCA results was not anticipated during clinical trial design. Consequently, options were not available for patients to indicate their preference for receiving their individual results when they signed pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual BRCA results to patients. Communicating the aggregate BRCA result from this study provided clinical investigators with a mechanism to disseminate the overall study finding to patients while taking individual circumstances, local guidelines and clinical practice into account. This study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results. This study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees. (shrink)

BackgroundWe conducted a survey to identify what types of health/medical research could be exempt from research ethics reviews in Australia.MethodsWe surveyed Australian health/medical researchers and Human Research Ethics Committee members. The survey asked whether respondents had previously changed or abandoned a project anticipating difficulties obtaining ethics approval, and presented eight research scenarios, asking whether these scenarios should or should not be exempt from ethics review, and to provide comments. Qualitative data were analysed thematically; quantitative data in R.ResultsWe received 514 responses. (...) Forty-three per cent of respondents to whom the question applied, reported changing projects in anticipation of obstacles from the ethics review process; 25% reported abandoning projects for this reason. Research scenarios asking professional staff to provide views in their area of expertise were most commonly exempted from ethics review ; scenarios involving surplus samples and N-of-1 studies were most commonly required to undergo ethics review. HREC members were 26% more likely than researchers to require ethics review. Need for independent oversight, and low risk, were most frequently cited in support of decisions to require or exempt from ethics review, respectively.ConclusionsConsiderable differences exist between researchers and HREC members, about when to exempt from review the research that ultimately serves the interests of patients and the public. It is widely accepted that evaluative research should be used to reduce clinical uncertainties—the same principle should apply to ethics reviews. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose (...) a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks (...) to subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (shrink)

Infants can anticipate the future location of a moving object and execute a predictive reach to intercept the object. When a moving object is temporarily hidden by darkness or occlusion, 6‐month‐old infants’ reaching is perturbed, but performance on darkness trials is significantly better than occlusion trials. How does this reaching behavior change over development? Experiment 1 tested predictive reaching of 6‐ and 9‐month‐old infants. While there was an increase in the overall number of reaches with increasing age, there (...) were significantly fewer predictive reaches during the occlusion compared to visible trials and no age‐related changes in this pattern. The decrease in performance found in Experiment 1 is likely to apply not only to the object representations formed by infants but also those formed by adults. In Experiment 2 we tested adults with a similar reaching task. Like infants, the adults were most accurate when the target was continuously visible and performance in darkness trials was significantly better than occlusion trials, providing evidence that there is something specific about occlusion that makes it more difficult than merely lack of visibility. Together, these findings suggest that infants’ and adults’ capacities to represent objects have similar signatures throughout development. (shrink)

The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy (...) raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder) from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1) direct participation of a multidisciplinary care team, including palliative care specialists, (2) a concise plan of care for anticipated device-related complications, (3) careful surveillance and counseling for caregiver burden, (4) advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5) a plan to address the long-term financial burden on patients, families, and caregivers. Short-term mechanical circulatory devices (e.g. percutaneous cardiopulmonary bypass, percutaneous ventricular assist devices, etc.) can be initiated in emergency situations as a bridge to permanent implantation of ventricular assist devices in chronic end-stage heart failure. In the absence of first-person (patient) consent, presumed consent or surrogate consent should be used cautiously for the initiation of short-term mechanical circulatory devices in emergency situations as a bridge to permanent implantation of left ventricular assist devices. Future clinical studies of destination therapy with left ventricular assist devices should include measures of recipients' quality of end-of-life care and caregivers' burden. (shrink)